Cleared Traditional

K921326 - DADE RECOMBOPLASTIN S

K921326 is an FDA 510(k) clearance for DADE RECOMBOPLASTIN S, manufactured by Baxter Diagnostics, Inc.. The device is a Class 2 Hematology device with product code GJS cleared through the Traditional 510(k) pathway after a 131-day FDA review.

K921326 · Baxter Diagnostics, Inc. · Hematology device
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Optimized for regulatory review, auditing and printing
Jul 1992
Decision
131d
Days
Class 2
Risk

K921326 is an FDA 510(k) clearance for the DADE RECOMBOPLASTIN S. Classified as Test, Time, Prothrombin (product code GJS), Class II - Special Controls.

Submitted by Baxter Diagnostics, Inc. (Miami, US). The FDA issued a Cleared decision on July 27, 1992 after a review of 131 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7750 - the FDA hematology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Baxter Diagnostics, Inc. devices

FDA 510(k) Submission Details - K921326

510(k) Number K921326 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 1992
Decision Date July 27, 1992
Days to Decision 131 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
18d slower than avg
Panel avg: 113d · This submission: 131d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GJS Device Classification - Class 2, Special Controls

Product Code GJS Test, Time, Prothrombin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7750
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Hematology devices follow this clearance model.

Regulatory Peers - GJS Test, Time, Prothrombin

All 113
Devices cleared under the same product code (GJS) and FDA review panel - the closest regulatory comparables to K921326.
ORTHO(TM) RECOMBIPLASTIN W/ORTHO DILUENT
K925604 · Ortho Diagnostic Systems, Inc. · Mar 1993
BIOMERIEUX HEMOLAB THROMBOMAT
K925492 · Biomerieux Vitek, Inc. · Feb 1993
NEOPLASTINE(R) CI KIT
K922565 · American Bioproducts Co. · Dec 1992
NEOPLASTINE CI PLUS
K922040 · American Bioproducts Co. · Jun 1992
SIMPLASTIN L
K915746 · Organon Teknika Corp. · Feb 1992
ACS ULTRA-1 THROMBOPLASTIN
K913249 · Analytical Control Systems, Inc. · Dec 1991